The recent edition of the NEJM contains an excellent article summarizing the differences between device approval and postmarketing surveillance regulations in the European Union [EU] & the US. Both have their pros & cons as it relates to allowing device innovation versus protecting the public safety and the quality of post marketing surveillance efforts to detect signals of device problems.
Points of interest -Class III devices [high risk implantables] approved through the US PMA process : one study showed that two-thirds of the PMA approvals were based on a single study, with these trials being rarely randomized or controlled, women were rarely studied, data was inconsistently reported.
Points of interest-510K approved devices in US: do not require clinical trials; one study showed that out of all the recalled devices, 71% were 510K approved; 7% were exempt from review [seriously???]; 25% of the reviews for high risk devices during a 4 year period were inadequately evaluated via the 510K process.
The US system will allow high risk devices used to treat rare conditions to be evaluated via the Humanitarian Device Exemption process which has strict post marketing follow up criteria.
There does need to be a regulatory pathway for device companies to develop innovative device technologies for various disease conditions, however, the key is to require adequate pre-clinical and biomaterials testing along with post-marketing surveillance system that is transparent to the public and can timely detect signals of adverse events. This early signal detection protects not only the public, but allows the manufacturers to make design changes to ensure the viability of their device in the marketplace. Hopefully the days of the 510K approvals based on outdated devices are over. Maybe..